Diabetes Mellitus, Type 2NCT01092663

The Effects of Co-admin of Colesevelam and Sitagliptin on Glucose Metabolism in Subjects With Type 2 Diabetes Mellitus

A study testing Colesevelam HCl and Sitagliptin in people with Diabetes Mellitus, Type 2, run by KineMed at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This study will assess the effects of colesevelam, alone or in combination with sitagliptin, on glucose metabolism in subjects with T2DM inadequately controlled by diet and exercise Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: Colesevelam HCl and Sitagliptin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 61 participants
Where: 3 sitesUnited States
Study dates: Mar 2010to Jul 2011
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or Female
Females of childbearing potential are on approved birth control method
Negative pregnancy testing for females of childbearing potential
Previously diagnosed or newly diagnosed with T2DM drug naïve subjects
HbA1c: 6.7-10%
Age 18 - 80 years

Show all 12Show fewer

BMI ≥ 18.5 kg/m2 and ≤ 40 kg/m2
Fasting serum glucose < 300 mg/dL
Normal liver function, normal thyroid function, no history of liver, biliary or intestinal disease
Normal TSH
On stable diet and exercise routine for at least 4 weeks prior to screening
Has had a stable weight (+/-5%) for ≥3 months before screening

Who cannot join

A history of type 1 diabetes mellitus or history of diabetic ketoacidosis
History of chronic (required daily for > 2 months) use of insulin therapy
Treatment with blood pressure lowering therapy that has not been stable for three months before screening
Treatment with lipid lowering medication other than statins
Treatment with statins that has not been stable for three months before screening
Treatment with a DPP-4 inhibitor or and GLP1 agonists at any time

Show all 16Show fewer

Treatment with a thiazolidinedione (TZD) within the last 6 months of screening
History of an allergic or toxic reaction to sitagliptin or colesevelam
History of dysphagia, swallowing disorders, bowel obstruction, intestinal motility disorder, and gastrointestinal disorders
History of major gastrointestinal surgery
History of kidney problems
Fasting plasma triglycerides > 300 mg/dL
Serum LDL-C <60 mg/dL
Positive toxicology test
Known hypersensitivity to colesevelam HCl or sitagliptin.
Any contraindications to a study medication (colesevelam HCl or sitagliptin).

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Clinical Pharmacology of Miami
Miami, Florida, 33014
Healthcare Discoveries, LLC d/b/a ICON Development Solutions
San Antonio, Texas, 78209
University of California, San Francisco
San Francisco, California, 94110

Other trials in United States

About this study

Official title: The Effects of Co-administration of Colesevelam and Sitagliptin on Glucose Metabolism in Patients With Type 2 Diabetes

This study will assess the effects of colesevelam, alone or in combination with sitagliptin, on glucose metabolism in subjects with T2DM inadequately controlled by diet and exercise

Read the detailed description

The hypothesis is that co-administrationof colesevelam plus sitagliptin results in a greater reduction in HbA1c compared to colesevelam HCl treatment by

improving the effects of colesevelam on fasting glucose metabolism
improving the effects of colsevelam on postprandial glucose metabolism

Conditions: Diabetes Mellitus, Type 2
Being tested: Colesevelam HCl, Sitagliptin
Keywords: Colesevelam, type 2 diabetes, sitagliptin, glucose metabolism
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Colesevelam HClDrug
Also called Welchol
Subjects will be given 3.75 g/day. Subjects will be given 3 tablets (625mg each) with breakfast and 3 tablets (625mg) with dinner for 12 weeks.
SitagliptinDrug
Also called Januvia
Subjects will be given 100mg/day. Subjects will be given 1 tablet (100mg) with breakfast for 12 weeks.

Study groups in NCT01092663
Study group	Role	What they receive
Colesevelam HCl: 3 tablets, 2x/day	Active comparator	Subjects will be given 3.75 g/day. Subjects will be given 3 tablets (625mg each) with breakfast and 3 tablets (625mg) with dinner for 12 weeks. Receives: Drug: Colesevelam HCl
Colesevelam plus Sitagliptin	Active comparator	Colesevelam: Subjects will be given 3.75 g/day. Subjects will be given 3 tablets (625mg each) with breakfast and 3 tablets (625mg) with dinner for 12 weeks. Sitagliptin: Subjects will be given 100mg/day. Subjects will be given 1 tablet (100mg) with breakfast for 12 weeks. Receives: Drug: Colesevelam HCl; Drug: Sitagliptin

What is being measured

The primary outcome is the main question the study is designed to answer.

Hemoglobin A1C
Change from baseline in hemoglobin A1C after 12 weeks of colesevelam or colesevelam plus sitagliptin treatments
Measured: Baseline and 12 weeks
Fasting Plasma Glucose
Change from baseline in fasting plasma glucose concentrations after 12 weeks of colesevelam or colesevelam plus sitagliptin treatments.
Measured: Baseline and 12 weeks
Fasting Endogenous Glucose Production
Change from baseline in fasting endogenous glucose production after 12 weeks of colesevelam alone or colesevelam plus sitagliptin treatment
Measured: baseline and 12 weeks
Fasting Gluconeogenesis
Change from baseline in fasting gluconeogenesis after 12 weeks of colesevelam alone or colesevelam plus sitagliptin treatment
Measured: baseline and 12 weeks
Fasting Glycogenolysis
Change from baseline in fasting glycogenolysis after 12 weeks of colesevelam alone or colesevelam plus sitagliptin treatment
Measured: baseline and 12 weeks
Fasting Plasma Glucose Clearance
Change from baseline in fasting plasma glucose clearance after 12 weeks of colesevelam alone or colesevelam plus sitagliptin treatments.
Measured: baseline and 12 weeks
Appearance Rate of Oral Glucose
Change from baseline in appearance rate of oral glucose after 12 weeks of colesevelam alone or colesevelam plus sitagliptin treatments
Measured: baseline and 12 weeks
Postprandial Endogenous Glucose Production
Change from baseline in postprandial endogenous glucose production after 12 weeks of colesevelam alone or colesevelam plus sitagliptin treatments
Mean value was calculated using all results measured between 10 and 300 min post meal.
Measured: baseline and 12 weeks
Postprandial Rate of Total Glucose Disposal Area Under the Curve (AUC)
Change from baseline in postprandial rate of total glucose disposal (AUC) after 12 weeks of colesevelam alone or colesevelam plus sitagliptin treatments
AUC was calculated by the trapezoid method using all results measured between 0 and 300 min during the meal tolerance test.
Measured: baseline and 12 weeks
Whole-body Glycolytic Disposal of Oral Glucose
Change in baseline in whole-body glycolytic disposal of oral glucose after 12 weeks of colesevelam alone or colesevelam plus glucose treatments
Measured: baseline and 12 weeks
Postprandial Glucose (AUC)
Comparison between baseline and 12 weeks values of postrandial glucose (AUC).
Measured: Baseline and 12 weeks

Secondary outcomes (10)

Fasting Plasma C-peptide
To evaluate the effect of treatments on plamsa C-peptide concentrations.
Measured: Baseline and 12 weeks
Fasting Plamsa Glucagon
To evaluate the effect of treatments on plasma glucagon concentrations.
Measured: Baseline and 12 weeks
Fasting Active Plasma Glucagon Like-Peptide 1 (GLP-1)
To evaluate the effect of treatments on plasma GLP-1 concentrations.
Measured: Baseline and 12 weeks
Fasting Plasma Total Glucose-dependent Insulinotropic Peptide (GIP)
To evaluate the effect of treatments on plasma Glucose-dependent Insulinotropic Peptide (GIP) concentrations.
Measured: Baseline and 12 weeks
Fasting Insulin
To evaluate the effect of treatments on fasting insulin concentrations
Measured: Baseline and 12 weeks
Postprandial Insulin (AUC)
To evaluate the effect of treatments on postprandial insulin (AUC)
Measured: Baseline and 12 weeks
Postprandial C-peptide (AUC)
To evaluate the effect of treatments on postprandial C-peptide (AUC)
Measured: Baseline and 12 weeks
Postprandial Active GLP-1 (AUC)
To evaluate the effects of treatments on postprandial active GLP-1 (AUC)
Measured: Baseline and 12 weeks
Postprandial Total GIP (AUC)
To evaluate the effects of treatment on postprandial total GIP (AUC)
Measured: Baseline and 12 weeks
Postprandial Glucagon (AUC)
To evaluate the effects of treatment on postprandial glucagon (AUC)
Measured: Baseline and 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2010Jul 2011

First posted25 Mar 2010 (estimated)
Study startMar 2010
Primary completionJul 2011
Study completionJul 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 61 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01092663
Sponsor's protocol ID: KM-29
Status last verified: Jan 2013
First submitted: 23 Mar 2010
Last updated: 17 Jan 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Zieve FJ, Kalin MF, Schwartz SL, Jones MR, Bailey WL. Results of the glucose-lowering effect of WelChol study (GLOWS): a randomized, double-blind, placebo-controlled pilot study evaluating the effect of colesevelam hydrochloride on glycemic control in subjects with type 2 diabetes. Clin Ther. 2007 Jan;29(1):74-83. doi: 10.1016/j.clinthera.2007.01.003.
PubMed 17379048
Bays HE, Goldberg RB, Truitt KE, Jones MR. Colesevelam hydrochloride therapy in patients with type 2 diabetes mellitus treated with metformin: glucose and lipid effects. Arch Intern Med. 2008 Oct 13;168(18):1975-83. doi: 10.1001/archinte.168.18.1975.
PubMed 18852398
Fonseca VA, Rosenstock J, Wang AC, Truitt KE, Jones MR. Colesevelam HCl improves glycemic control and reduces LDL cholesterol in patients with inadequately controlled type 2 diabetes on sulfonylurea-based therapy. Diabetes Care. 2008 Aug;31(8):1479-84. doi: 10.2337/dc08-0283. Epub 2008 May 5.
PubMed 18458145
Goldberg RB, Fonseca VA, Truitt KE, Jones MR. Efficacy and safety of colesevelam in patients with type 2 diabetes mellitus and inadequate glycemic control receiving insulin-based therapy. Arch Intern Med. 2008 Jul 28;168(14):1531-40. doi: 10.1001/archinte.168.14.1531.
PubMed 18663165
Aschner P, Kipnes MS, Lunceford JK, Sanchez M, Mickel C, Williams-Herman DE; Sitagliptin Study 021 Group. Effect of the dipeptidyl peptidase-4 inhibitor sitagliptin as monotherapy on glycemic control in patients with type 2 diabetes. Diabetes Care. 2006 Dec;29(12):2632-7. doi: 10.2337/dc06-0703.
PubMed 17130196
Nauck MA, Meininger G, Sheng D, Terranella L, Stein PP; Sitagliptin Study 024 Group. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor, sitagliptin, compared with the sulfonylurea, glipizide, in patients with type 2 diabetes inadequately controlled on metformin alone: a randomized, double-blind, non-inferiority trial. Diabetes Obes Metab. 2007 Mar;9(2):194-205. doi: 10.1111/j.1463-1326.2006.00704.x.
PubMed 17300595
Goldstein BJ, Feinglos MN, Lunceford JK, Johnson J, Williams-Herman DE; Sitagliptin 036 Study Group. Effect of initial combination therapy with sitagliptin, a dipeptidyl peptidase-4 inhibitor, and metformin on glycemic control in patients with type 2 diabetes. Diabetes Care. 2007 Aug;30(8):1979-87. doi: 10.2337/dc07-0627. Epub 2007 May 7.
PubMed 17485570

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 17 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effects of Co-administration of Colesevelam and Sitagliptin on Glucose Metabolism in Patients With Type 2 Diabetes
ClinicalTrials.gov ID: NCT01092663
Acronym / sponsor ID: KM-29
Conditions: Diabetes Mellitus, Type 2
Keywords: Colesevelam, type 2 diabetes, sitagliptin, glucose metabolism
Study type: Interventional
Recruitment status: Completed
Enrolment: 61 participants (actual)
Lead sponsor: KineMedIndustry (pharma, biotech, devices)
Study start: Mar 2010
Primary completion: Jul 2011 (actual)
Study completion: Jul 2011 (actual)
First posted: 25 Mar 2010 (estimated)
Results: Posted 17 Jan 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study will assess the effects of colesevelam, alone or in combination with sitagliptin, on glucose metabolism in subjects with T2DM inadequately controlled by diet and exercise

Detailed description

The hypothesis is that co-administrationof colesevelam plus sitagliptin results in a greater reduction in HbA1c compared to colesevelam HCl treatment by

improving the effects of colesevelam on fasting glucose metabolism
improving the effects of colsevelam on postprandial glucose metabolism

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Colesevelam HCl: 3 tablets, 2x/day	Active comparator	Drug: Colesevelam HClSubjects will be given 3.75 g/day. Subjects will be given 3 tablets (625mg each) with breakfast and 3 tablets (625mg) with dinner for 12 weeks.
Colesevelam plus Sitagliptin	Active comparator	Drug: Colesevelam HCl, Drug: SitagliptinColesevelam: Subjects will be given 3.75 g/day. Subjects will be given 3 tablets (625mg each) with breakfast and 3 tablets (625mg) with dinner for 12 weeks. Sitagliptin: Subjects will be given 100mg/day. Subjects will be given 1 tablet (100mg) with breakfast for 12 weeks.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

Male or Female
Females of childbearing potential are on approved birth control method
Negative pregnancy testing for females of childbearing potential
Previously diagnosed or newly diagnosed with T2DM drug naïve subjects
HbA1c: 6.7-10%

Key exclusion criteria (16 listed)

A history of type 1 diabetes mellitus or history of diabetic ketoacidosis
History of chronic (required daily for > 2 months) use of insulin therapy
Treatment with blood pressure lowering therapy that has not been stable for three months before screening
Treatment with lipid lowering medication other than statins
Treatment with statins that has not been stable for three months before screening

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Colesevelam HClAlso: WelcholSubjects will be given 3.75 g/day. Subjects will be given 3 tablets (625mg each) with breakfast and 3 tablets (625mg) with dinner for 12 weeks.	Drug	Colesevelam HCl: 3 tablets, 2x/day, Colesevelam plus Sitagliptin
SitagliptinAlso: JanuviaSubjects will be given 100mg/day. Subjects will be given 1 tablet (100mg) with breakfast for 12 weeks.	Drug	Colesevelam plus Sitagliptin

Primary outcome

Hemoglobin A1C
Time frame: Baseline and 12 weeks
Change from baseline in hemoglobin A1C after 12 weeks of colesevelam or colesevelam plus sitagliptin treatments
Fasting Plasma Glucose
Time frame: Baseline and 12 weeks
Change from baseline in fasting plasma glucose concentrations after 12 weeks of colesevelam or colesevelam plus sitagliptin treatments.
Fasting Endogenous Glucose Production
Time frame: baseline and 12 weeks
Change from baseline in fasting endogenous glucose production after 12 weeks of colesevelam alone or colesevelam plus sitagliptin treatment
Fasting Gluconeogenesis
Time frame: baseline and 12 weeks
Change from baseline in fasting gluconeogenesis after 12 weeks of colesevelam alone or colesevelam plus sitagliptin treatment
Fasting Glycogenolysis
Time frame: baseline and 12 weeks
Change from baseline in fasting glycogenolysis after 12 weeks of colesevelam alone or colesevelam plus sitagliptin treatment
Fasting Plasma Glucose Clearance
Time frame: baseline and 12 weeks
Change from baseline in fasting plasma glucose clearance after 12 weeks of colesevelam alone or colesevelam plus sitagliptin treatments.
Appearance Rate of Oral Glucose
Time frame: baseline and 12 weeks
Change from baseline in appearance rate of oral glucose after 12 weeks of colesevelam alone or colesevelam plus sitagliptin treatments
Postprandial Endogenous Glucose Production
Time frame: baseline and 12 weeks
Change from baseline in postprandial endogenous glucose production after 12 weeks of colesevelam alone or colesevelam plus sitagliptin treatments Mean value was calculated using all results measured between 10 and 300 min post meal.
Postprandial Rate of Total Glucose Disposal Area Under the Curve (AUC)
Time frame: baseline and 12 weeks
Change from baseline in postprandial rate of total glucose disposal (AUC) after 12 weeks of colesevelam alone or colesevelam plus sitagliptin treatments AUC was calculated by the trapezoid method using all results measured between 0 and 300 min during the meal tolerance test.
Whole-body Glycolytic Disposal of Oral Glucose
Time frame: baseline and 12 weeks
Change in baseline in whole-body glycolytic disposal of oral glucose after 12 weeks of colesevelam alone or colesevelam plus glucose treatments
Postprandial Glucose (AUC)
Time frame: Baseline and 12 weeks
Comparison between baseline and 12 weeks values of postrandial glucose (AUC).

10 secondary outcomes

Fasting Plasma C-peptide
Time frame: Baseline and 12 weeks
Fasting Plamsa Glucagon
Time frame: Baseline and 12 weeks
Fasting Active Plasma Glucagon Like-Peptide 1 (GLP-1)
Time frame: Baseline and 12 weeks
Fasting Plasma Total Glucose-dependent Insulinotropic Peptide (GIP)
Time frame: Baseline and 12 weeks
Fasting Insulin
Time frame: Baseline and 12 weeks
Postprandial Insulin (AUC)
Time frame: Baseline and 12 weeks
Postprandial C-peptide (AUC)
Time frame: Baseline and 12 weeks
Postprandial Active GLP-1 (AUC)
Time frame: Baseline and 12 weeks
Postprandial Total GIP (AUC)
Time frame: Baseline and 12 weeks
Postprandial Glucagon (AUC)
Time frame: Baseline and 12 weeks

Results and safety

Results posted to the registry on 17 Jan 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Colesevelam	31	24
Colesevelam Plus Sitagliptin	30	26

Primary outcome: Hemoglobin A1C

Time frame: Baseline and 12 weeks. Mean (Standard Deviation). Unit: percentage

Measure	Colesevelam n = 24	Colesevelam Plus Sitagliptin n = 26
Value	0.3 (1.2)	-0.1 (1.1)

Colesevelam vs Colesevelam Plus Sitagliptin: p >0.05, t-test, 2 sided

Primary outcome: Fasting Plasma Glucose

Time frame: Baseline and 12 weeks. Mean (Standard Deviation). Unit: millimoles (mmol)/Liter (L)

Measure	Colesevelam n = 24	Colesevelam Plus Sitagliptin n = 26
Value	-0.8 (2.1)	-0.6 (2.3)

Colesevelam vs Colesevelam Plus Sitagliptin: p >0.05, t-test, 2 sided

Primary outcome: Fasting Endogenous Glucose Production

Time frame: baseline and 12 weeks. Mean (Standard Deviation). Unit: micromoles (umol) per kg FFM per min

Measure	Colesevelam n = 24	Colesevelam Plus Sitagliptin n = 26
Value	1.0 (4.4)	1.0 (3.3)

Colesevelam vs Colesevelam Plus Sitagliptin: p >0.05, t-test, 2 sided

Primary outcome: Fasting Gluconeogenesis

Time frame: baseline and 12 weeks. Mean (Standard Deviation). Unit: umol per kilogram (kg) FFM per min

Measure	Colesevelam n = 24	Colesevelam Plus Sitagliptin n = 26
Value	0.2 (1.5)	-0.3 (1.3)

Colesevelam vs Colesevelam Plus Sitagliptin: p >0.05, t-test, 2 sided

10 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Colesevelam	0 of 31 (0%)	1 of 31 (3.2%)	Not reported
Colesevelam Plus Sitagliptin	0 of 30 (0%)	1 of 30 (3.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 17379048Zieve FJ, Kalin MF, Schwartz SL, Jones MR, Bailey WL. Results of the glucose-lowering effect of WelChol study (GLOWS): a randomized, double-blind, placebo-controlled pilot study evaluating the effect of colesevelam hydrochloride on glycemic control in subjects with type 2 diabetes. Clin Ther. 2007 Jan;29(1):74-83. doi: 10.1016/j.clinthera.2007.01.003.
Background: PubMed 18852398Bays HE, Goldberg RB, Truitt KE, Jones MR. Colesevelam hydrochloride therapy in patients with type 2 diabetes mellitus treated with metformin: glucose and lipid effects. Arch Intern Med. 2008 Oct 13;168(18):1975-83. doi: 10.1001/archinte.168.18.1975.
Background: PubMed 18458145Fonseca VA, Rosenstock J, Wang AC, Truitt KE, Jones MR. Colesevelam HCl improves glycemic control and reduces LDL cholesterol in patients with inadequately controlled type 2 diabetes on sulfonylurea-based therapy. Diabetes Care. 2008 Aug;31(8):1479-84. doi: 10.2337/dc08-0283. Epub 2008 May 5.
Background: PubMed 18663165Goldberg RB, Fonseca VA, Truitt KE, Jones MR. Efficacy and safety of colesevelam in patients with type 2 diabetes mellitus and inadequate glycemic control receiving insulin-based therapy. Arch Intern Med. 2008 Jul 28;168(14):1531-40. doi: 10.1001/archinte.168.14.1531.
Background: PubMed 17130196Aschner P, Kipnes MS, Lunceford JK, Sanchez M, Mickel C, Williams-Herman DE; Sitagliptin Study 021 Group. Effect of the dipeptidyl peptidase-4 inhibitor sitagliptin as monotherapy on glycemic control in patients with type 2 diabetes. Diabetes Care. 2006 Dec;29(12):2632-7. doi: 10.2337/dc06-0703.
Background: PubMed 17300595Nauck MA, Meininger G, Sheng D, Terranella L, Stein PP; Sitagliptin Study 024 Group. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor, sitagliptin, compared with the sulfonylurea, glipizide, in patients with type 2 diabetes inadequately controlled on metformin alone: a randomized, double-blind, non-inferiority trial. Diabetes Obes Metab. 2007 Mar;9(2):194-205. doi: 10.1111/j.1463-1326.2006.00704.x.
Background: PubMed 17485570Goldstein BJ, Feinglos MN, Lunceford JK, Johnson J, Williams-Herman DE; Sitagliptin 036 Study Group. Effect of initial combination therapy with sitagliptin, a dipeptidyl peptidase-4 inhibitor, and metformin on glycemic control in patients with type 2 diabetes. Diabetes Care. 2007 Aug;30(8):1979-87. doi: 10.2337/dc07-0627. Epub 2007 May 7.
Ethics and ComplianceLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Carine Beysen, DPhil principal investigator

KineMed, Inc.

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Colesevelam HCl and Sitagliptin in people with Diabetes Mellitus, Type 2, run by KineMed at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Jan 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hemoglobin A1C (time frame: Baseline and 12 weeks). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01092663, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2013.